OKITASK * OS GRAT 10BUST 40MG
Pain of different origins and nature, and in particular: headache, toothache, neuralgia, menstrual pain, muscle and bone pain.
Dosage and method of use
Dosage.Adults and over 15 years: the recommended dose is 40 mg (corresponding to 1 sachet), in a single dose, or repeated 2-3 times a day, in the painful forms of greater intensity. Do not exceed the recommended doses.Special populations. Senior citizens:The posology must be carefully established taking into consideration a possible reduction of the dosages indicated above.Patients with hepatic or renal insufficiency:Minimum daily dosage therapy and careful monitoring are recommended (see section 4.4). In case of renal insufficiency it is recommended to monitor the volume of urine output and renal function (see section 4.4). Okitask 40 mg granules must not be used in patients with severe hepatic or renal dysfunction (see section 4.3).Pediatric population:The safety and efficacy of Okitask 40 mg granules in children have not yet been established.Method of administration:The contents of the sachet can be placed directly on the tongue. It dissolves with saliva: this allows it to be used without water. It is preferable to take the product on a full stomach.Duration of treatment:The duration of the therapy must be limited to the overcoming of the painful episode. The lowest effective dose should be used for the shortest time necessary to relieve symptoms (see section 4.4).
Okitask 40 mg granules must not be administered in the following cases: • hypersensitivity to the active substance, to other non-steroidal anti-inflammatory drugs (NSAIDs) or to any of the excipients, listed in section 6.1; • asthma, bronchospasm, acute rhinitis, urticaria, skin rash, nasal polyps, angioneurotic edema or other allergic-type reactions caused by ketoprofen, or by medicines with a similar mechanism of action (for example acetylsalicylic acid, other NSAIDs and selective cycle inhibitors -oxygenase 2), see section 4.8; • previous bronchial asthma; • severe heart failure; • gastritis; • active peptic ulcer / haemorrhage or history of recurrent peptic ulcer / haemorrhage (two or more distinct episodes of proven ulceration or haemorrhage); • a history of gastrointestinal bleeding, ulceration or perforation or chronic dyspepsia; • history of gastrointestinal bleeding or perforation following previous NSAID therapy; • Crohn's disease or ulcerative colitis; • severe hepatic insufficiency (liver cirrhosis, severe hepatitis); • severe renal insufficiency; • leukopenia and thrombocytopenia; • bleeding diathesis and other coagulation disorders, haemostatic disorders; • use of a high dosage of diuretics; • third trimester of pregnancy; • children under 15 years of age.
The most commonly observed adverse events are gastrointestinal in nature. Classification of expected frequencies: very common (1/10), common (1/100 to ≤1 / 10), uncommon (1/1000 to ≤1 / 100), rare (1/10000 to ≤1 / 1000), very rare (≤1 / 10000), not known (cannot be estimated from the available data). The following adverse reactions have been observed with the use of ketoprofen in adults:
| MedDRA System Organ Class || Very common (≥1 / 10) || Common (≥1 / 100, || Uncommon (≥1 / 1,000 to || Rare (≥1 / 10,000, || Very rare ( || Frequency not known |
|Disorders of the blood and lymphatic system || || || ||hemorrhagic anemia || ||thrombocytopenia, agranulocytosis, bone marrow failure, haemolytic anemia, leukopenia, neutropenia, aplastic anemia, leukocytosis, thrombocytopenic purpura. |
|Disorders of the immune system || || || || || ||anaphylactic reaction (including shock), hypersensitivity |
|Gastrointestinal disorders || ||dyspepsia, nausea, abdominal pain, vomiting ||constipation, diarrhea, flatulence, gastritis ||stomatitis, peptic ulcer || ||exacerbation of colitis and Crohn's disease, gastrointestinal haemorrhage, gastrointestinal perforation (sometimes fatal, particularly in the elderly - see section 4.4), gastric ulcer, mouth ulceration, duodenal ulcer, duodenal perforation, melaena, haematemesis, abdominal discomfort, colitis, heartburn, mouth edema, pancreatitis, hyperchlorhydria, gastric pain, erosive gastritis, tongue edema |
|Skin and subcutaneous tissue disorders || || ||rash, itching || ||erythema ||photosensitivity reaction, alopecia, urticaria, angioedema, bullous dermatitis including Stevens-Johnson syndrome and toxic epidermal necrolysis, edema, rash, Lyell's syndrome, maculo-papular rash, purpura, acute generalized exanthematous pustulosis, dermatitis |
|General disorders and administration site conditions || || ||fatigue, || ||edema of the face ||peripheral edema, chills, asthenia |
|Nervous system disorders || || ||headache, dizziness, drowsiness ||paraesthesia || ||seizure, dysgeusia, dizziness, dyskinesia, syncope, tremor, hyperkinesia |
|Eye disorders || || || ||blurred vision (see section 4.4) || ||periorbital edema |
|Ear and labyrinth disorders || || || ||tinnitus || || |
|Hepatobiliary disorders || || || ||hepatitis, transaminases increased, blood bilirubin increased || ||jaundice |
|Respiratory, thoracic and mediastinal disorders || || || ||asthma || ||bronchospasm (especially in patients with known hypersensitivity to acetylsalicylic acid and other NSAIDs), rhinitis, dyspnoea, edema of the larynx, laryngospasm, acute respiratory failure (a fatal case has been reported in an asthmatic and sensitive patient acetylsalicylic acid). |
|Renal and urinary disorders: || || || || || ||acute renal failure, tubulointerstitial nephritis, nephritic syndrome, renal function test abnormal, haematuria, nephritis, nephrotic syndrome, glomerulonephritis, sodium / water retention with possible edema, acute tubular necrosis, renal papillary necrosis, oliguria |
|Psychiatric disorders || || || || || ||altered mood, depression, hallucination, confusion, agitation, insomnia |
|Cardiac pathologies || || || || || ||heart failure, atrial fibrillation, palpitations, tachycardia |
|Vascular pathologies || || || || || ||hypertension, vasodilation, hypotension, vasculitis (including leukocytoclastic vasculitis) |
|Metabolism and nutrition disorders || || || || || ||hyperkalaemia, hyponatraemia |
|Infections and infestations || || || || || ||aseptic meningitis, lymphangitis |
|Diagnostic tests || || || ||Increased weight || || |
Clinical studies and epidemiological data suggest that the use of some NSAIDs (especially at high doses and for long-term treatment) may be associated with an increased risk of arterial thrombotic events (e.g. myocardial infarction or stroke) (see paragraph 4.4).Reporting of suspected adverse reactions.Reporting of suspected adverse reactions that occur after authorization of the medicine is important, as it allows continuous monitoring of the benefit / risk ratio of the medicine. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Warnings: Undesirable effects can be minimized by using the lowest effective dose for the shortest possible duration of treatment needed to control symptoms (see section 4.2 and the sections below on gastrointestinal and cardiovascular risks). The concomitant use of Okitask 40 mg granules with other NSAIDs, including selective cyclooxygenase-2 inhibitors, should be avoided.Gastrointestinal reactions:Gastrointestinal bleeding, ulceration and perforation: Gastrointestinal bleeding, ulceration and perforation, which can be fatal, have been reported during treatment with all NSAIDs, at any time, with or without warning symptoms or a previous history of serious gastrointestinal events. In patients with a history of ulcer, particularly if complicated with haemorrhage or perforation (see section 4.3), the risk of gastrointestinal bleeding, ulceration or perforation is higher with increasing doses of NSAIDs. These patients should start treatment with the lowest possible dose. Concomitant use of protective agents (misoprostol or proton pump inhibitors) should be considered for these patients and also for patients taking concomitantly low doses of acetylsalicylic acid or other drugs that may increase the risk of gastrointestinal events (see below and section 4.5). Patients with a history of gastrointestinal toxicity, especially the elderly, should report any abdominal symptoms and / or signs (including gastrointestinal bleeding) even at the start of treatment. Caution should be exercised in patients taking concomitant medications that may increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin reuptake inhibitors or antiplatelet agents such as acetylsalicylic acid (see section 4.5).Senior citizens:The elderly have an increased frequency of adverse reactions to NSAIDs, especially gastrointestinal bleeding and perforation, which can be fatal (see section 4.2). Patients with current or previous gastrointestinal disease should be carefully monitored for the appearance of digestive disturbances, especially gastrointestinal bleeding. When gastrointestinal bleeding or ulceration occurs in patients taking Okitask 40 mg granules the treatment should be discontinued.Patients with active or previous peptic ulcer:Some epidemiological evidence suggests that ketoprofen may be associated with a higher risk of serious gastrointestinal toxicity compared to other NSAIDs, especially at high doses (see sections 4.2 and 4.3).Skin reactions:Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at higher risk at the start of treatment. Okitask 40 mg granules should be discontinued at the first appearance of skin rash, mucosal lesions or any other signs of hypersensitivity. Precautions.Cardiovascular, renal and hepatic dysfunction:In patients with impaired renal function the administration of ketoprofen should be carried out with particular caution in consideration of the essentially renal elimination of the drug. Renal function should be carefully monitored in patients with heart failure, cirrhosis and nephrosis, in patients receiving diuretic therapy, in patients with chronic renal impairment, particularly if the patients are elderly. In these patients, administration of ketoprofen may result in decreased renal blood flow caused by inhibition of prostaglandins and lead to renal failure (see section 4.3). Caution is also required in patients undergoing diuretic therapy or who are likely to be hypovolaemic because the risk of nephrotoxicity is increased. As with all NSAIDs, Okitask 40 mg granules can increase plasma urea nitrogen and creatinine. As with other prostaglandin synthesis inhibitors, Okitas 40 mg granules may be associated with adverse events on the renal system which may lead to glomerular nephritis, renal papillary necrosis, nephrotic syndrome and acute renal failure (see section 4.8). In patients with abnormal liver function values or with a history of liver disease, transaminase levels should be evaluated periodically. As with other NSAIDs, Okitask 40 mg granules may cause increases in some liver parameters and also significant increases in SGOT and SGPT (see section 4.8). In the event of a significant increase in these parameters, therapy must be discontinued. Cases of jaundice and hepatitis have been reported with the use of ketoprofen (see section 4.8). Elderly patients are more prone to decreased renal, cardiovascular or hepatic function.Cardiovascular and cerebrovascular effects:As with other NSAIDs, patients with uncontrolled hypertension, congestive heart failure, established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease should only be treated with ketoprofen after careful consideration. Similar considerations should be made before starting treatment in patients with risk factors for cardiovascular disease (eg hypertension, hyperlipidaemia, diabetes mellitus, smoking). Caution is required before starting treatment in patients with a history of hypertension and / or mild to moderate congestive heart failure as fluid retention and edema related to NSAID treatment have been reported. Clinical studies and epidemiological data suggest that the use of some NSAIDs may be associated with an increased risk of arterial thrombotic events (eg myocardial infarction or stroke). There are insufficient data to exclude a similar risk for Okitask 40 mg granules An increased risk of atrial fibrillation associated with the use of NSAIDs has been reported. Hyperkalaemia may occur, especially in patients with underlying diabetes, renal insufficiency, and / or concomitant treatment with hyperkalaemia promoting agents (see section 4.5). In these circumstances, potassium levels need to be assessed periodically.Infections.Masking the symptoms of underlying infections: Okitask 40 mg granules can mask the symptoms of infection, which could delay the initiation of adequate treatment and therefore worsen the outcome of the infection. This has been observed in community-acquired bacterial pneumonia and bacterial complications of chickenpox. When Okitask 40 mg granules are administered for the relief of infection-related fever or pain, monitoring of the infection is advised. In non-hospital settings, the patient should seek medical attention if symptoms persist or worsen.Respiratory disorders:Like all non-steroidal drugs, the use of ketoprofen in patients with bronchial asthma or with allergic diathesis can cause an asthmatic crisis. Patients with asthma associated with chronic rhinitis, chronic sinusitis and / or nasal polyposis are at greater risk of allergy to acetylsalicylic acid and / or NSAIDs than the rest of the population. The administration of this drug can cause asthma attacks or bronchospasm, shock and other allergic phenomena especially in subjects allergic to acetylsalicylic acid or NSAIDs (see section 4.3). Due to the action on the metabolism of arachidonic acid, bronchospasm crises and possibly shock and other allergic phenomena may arise in asthmatics and predisposed subjects. Administer with caution in patients with allergic manifestations or previous allergy.Visual disturbances:In case of visual disturbances, such as blurred vision, treatment should be stopped. Okitask 40 mg granules should be administered with caution in patients with haematopoietic disorders, systemic lupus erythematosus or mixed connective tissue disorders. Caution is required when Okitask 40 mg granules are administered to patients with hepatic porphyria as it could trigger an attack. Important information about some of the ingredients: Okitask 40 mg granules contain less than 1mmol (23 mg) sodium per sachet, i.e. essentially 'sodium-free'. Okitask 40 mg granules contain lemon flavor and lime flavor. The lemon flavor contains sucrose. Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption, or sucrase-isomaltase insufficiency should not take this medicine. Glucose is contained in the lime flavor. Patients with rare glucose-galactose malabsorption problems should not take this medicine.
Pregnancy and breastfeeding
Pregnancy:The use of ketoprofen during the first and second trimester of pregnancy should be avoided, administration of ketoprofen should only be considered if the expected benefit to the mother outweighs the risk to the embryo or fetus. Inhibition of prostaglandin synthesis can adversely affect pregnancy and / or embryo / fetal development. Results of epidemiological studies suggest an increased risk of miscarriage and cardiac malformation and gastroschisis after use of a prostaglandin synthesis inhibitor in early pregnancy. The absolute risk of cardiac malformations increased from less than 1% to approximately 1.5%. The risk was considered to increase with dose and duration of therapy. In animals, administration of prostaglandin synthesis inhibitors has been shown to cause increased pre- and post-implantation loss and embryo-fetal mortality. In addition, an increased incidence of various malformations, including cardiovascular, has been reported in animals given prostaglandin synthesis inhibitors during the organogenetic period. Therefore ketoprofen should not be administered during the first and second trimester of pregnancy unless strictly necessary. If ketoprofen is used by a woman who wishes to become pregnant, or during the first and second trimester of pregnancy, the dosage should be kept as low as possible for the shortest possible duration of treatment. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors can expose the fetus to: - cardiopulmonary toxicity (with premature closure of the arterial duct and pulmonary hypertension); - renal dysfunction, which can progress to renal failure with oligo-hydroamnios; the mother and the newborn, at the end of pregnancy, to: - possible prolongation of the bleeding time and antiplatelet effect which may occur even at very low doses; - inhibition of uterine contractions resulting in delayed or prolonged labor. The use of the medicine close to the birth can cause haemodynamics alterations of the small circulation of the unborn child with serious consequences for the respiration. Consequently, ketoprofen is contraindicated during the third trimester of pregnancy.Feeding time:There is no information available on the excretion of ketoprofen in human milk. Ketoprofen is not recommended while breastfeeding.Fertility:The use of NSAIDs may reduce female fertility and is therefore not recommended in women planning to become pregnant. The administration of NSAIDs, as well as of Okitask 40 mg granules, should be discontinued in women who have fertility problems or who are undergoing fertility investigations.
Expiry and retention
This medicine does not require any special storage conditions.
Interactions with other drugs
Combinations not recommended.- Other NSAIDs (including selective cyclooxygenase 2 inhibitors) and high doses of salicylates (> 3 g / day): the simultaneous administration of several NSAIDs can increase the risk of gastrointestinal ulcers and bleeding, due to a synergistic effect. - Anticoagulants (heparin and warfarin): NSAIDs can amplify the effects of anticoagulants. If co-administration cannot be avoided, the patient should be closely monitored. - Platelet aggregation inhibitors (ticlopidine and clopidogrel): co-administration of an NSAID may increase the risk of bleeding due to inhibition of platelet function and damage to the gastrointestinal mucosa (see section 4.4). If co-administration cannot be avoided, the patient should be closely monitored. - Lithium: the simultaneous administration of different NSAIDs can increase plasma lithium levels, which can reach toxic values, due to reduced renal excretion. Plasma lithium levels should be closely monitored and the lithium dosage adjusted during and after discontinuation of ketoprofen and other NSAIDs. - Methotrexate, at doses higher than 15 mg / week: co-administration of an NSAID may increase the risk of methotrexate blood toxicity, especially when administered at high doses, possibly due to a displacement of plasma protein binding and a decrease in renal clearance . The intake of the two medicines must be separated by at least 12 hours. - Hydantoins and sulfonamides: the toxic effects of these substances can be increased; since the protein binding of ketoprofen is high, it may be necessary to reduce the dosage of diphenylhydantoin or sulfonamides in case of concomitant administration.Associations requiring precaution.- Drugs or therapeutic categories that can promote hyperkalaemia: potassium salts, potassium-sparing diuretics, enzyme converter inhibitors (ACE inhibitors), angiotensin II receptor blockers, NSAIDs, heparins (low molecular weight or unfractionated ), cyclosporine, tacrolimus and trimethoprim. The occurrence of hyperkalaemia may depend on the presence of cofactors. The risk is increased in case of simultaneous administration of the drugs mentioned above. - Tenofovir: Concomitant administration of tenofovir disoproxil fumarate and NSAIDs may increase the risk of renal failure. - Diuretics: subjects treated with diuretics, especially in case of dehydration, are more at risk of developing renal failure secondary to the reduction in renal blood flow caused by the inhibition of prostaglandins. Hydration is recommended before initiating concomitant therapy and close monitoring of renal function after initiation of treatment (see section 4.4). NSAIDs can reduce the effect of diuretics. - ACE inhibitors and angiotensin II antagonists: co-administration with cyclo-oxygenase inhibitors may lead to further deterioration of renal function and possible acute renal failure especially in dehydrated and elderly subjects. Caution, hydration and monitoring of renal function are recommended in case of joint therapy. - Methotrexate at doses lower than 15 mg / week: anti-inflammatories cause a decrease in the renal clearance of methotrexate with a consequent increase in haematic toxicity. In case of impaired renal function or advanced age, the monitoring should have a higher frequency. - Corticosteroids: co-administration of NSAIDs may increase the risk of gastrointestinal ulceration or bleeding (see section 4.4). - Pentoxifylline: co-administration may lead to an increased risk of bleeding: monitoring of bleeding time is recommended. - Zidovudine: the combination with NSAIDs increases the risk of reticulocyte toxicity, with severe anemia occurring one week after starting treatment with NSAIDs. Complete blood count and reticulocyte counts should be checked one week after starting NSAID treatment. - Sulfonylureas: NSAIDs can increase the hypoglycemic effect of sulfonylureas by displacing them from binding sites with plasma proteins. Any interactions with other oral hypoglycemic agents should also be considered. - Cardiac glycosides: NSAIDs can exacerbate heart failure, reduce the rate of glomerular filtration and increase the levels of cardiac glycosides; however, the pharmacokinetic interaction between ketoprofen and active glycosides has not been demonstrated.Associations that need to be considered.- Antihypertensive agents (Beta-blockers, ACE inhibitors, diuretics): treatment with an NSAID can reduce the effect of antihypertensive drugs by inhibiting the synthesis of vasodilating prostaglandins. - Mifepristone: the effectiveness of the contraceptive method can theoretically be reduced due to the antiprostaglandin properties of NSAIDs including acetylsalicylic acid. There is some evidence to suggest that co-administration of NSAIDs on the day of administration of the prostaglandin dose does not adversely affect the effects of mifepristone or prostaglandin on cervical ripening or uterine contractility and does not reduce the clinical efficacy of medical discontinuation. of pregnancy. - Intrauterine contraceptive devices (IUDs): the effectiveness of the device may be reduced resulting in pregnancy. - Ciclosporin and tacrolimus: simultaneous treatment with NSAIDs may involve a greater risk of nephrotoxicity, especially in elderly subjects. - Thrombolytics: co-administration with NSAIDs may increase the risk of bleeding. - Anti-aggregating agents (ticlopidine and clopidogrel) and Selective Serotonin Reuptake Inhibitors (SSRIs): NSAIDs may increase the risk of gastrointestinal bleeding (see section 4.4). - Probenecid: Concomitant administration of probenecid may markedly reduce the plasma clearance of ketoprofen by inhibition of tubular secretion and glucuronoconjugation, therefore a dose adjustment of ketoprofen is required. - Quinolone antibiotics: Animal data indicate that NSAIDs may increase the risk of seizures related to the use of quinolones. Patients being treated with NSAIDs and quinolones may have an increased risk of developing seizures. - Diphenylhydantoin and sulfonamides: since the protein binding of ketoprofen is high, it may be necessary to reduce the dosage of diphenylhydantoin or sulfonamides in case of co-administration. - Gemeprost: use in conjunction with an NSAID can reduce its effectiveness. Alcohol intake during treatment is to be avoided.
Cases of overdose have been reported with doses up to 2.5 g of ketoprofen. In most cases, the symptoms observed were limited to lethargy, confusion, loss of consciousness, somnolence, headache, dizziness, dizziness, nausea, vomiting, epigastric pain, abdominal pain and diarrhea. In the event of a severe overdose, gastrointestinal bleeding, hypotension, respiratory depression and cyanosis may also occur, in which case the patient should be immediately transferred to a specialized hospital to begin symptomatic treatment. There is no specific antidote to ketoprofen overdose. In the event of suspected massive overdose, gastric lavage is recommended and symptomatic and supportive treatment instituted to compensate for dehydration, monitor urinary excretion and correct acidosis, if present. In cases of kidney failure, hemodialysis can be helpful in removing the drug from the bloodstream.
Each sachet contains: Active ingredient: ketoprofen 40 mg lysine salt (corresponding to 25 mg of ketoprofen). Excipients with known effect: aspartame, sodium dodecyl sulfate. For the full list of excipients, see section 6.1.
Povidone, colloidal silica, hydroxypropylmethylcellulose, eudragit EPO, sodium dodecyl sulfate, stearic acid, magnesium stearate, aspartame, mannitol, xylitol, talc, lime flavor, lemon flavor, fresh flavor.